MAUDE Adverse Event Report: BOSTON SCIENTIFIC NEUROMODULATION SPECTRA WAVEWRITER; STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF

Model Number SC-1160

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Bacterial Infection (1735); Staphylococcus Aureus (2058); Fluid Discharge (2686); No Code Available (3191); Swelling/ Edema (4577)

Event Date 02/01/2020

Event Type  Injury  

Manufacturer Narrative

Exact date unknown, event occurred in (b)(6) 2020.Additional suspect medical device component involved in the event: product family: scs-paddle leads, upn: (b)(4), model: sc-8336-70, serial: (b)(4), batch: 7052719.

Event Description

It was reported that the patient developed an infection at the ipg and lead incision sites.Symptoms of infection were wound drainage and the incision sites were hot to touch.The physician believed that the infection was device related and not procedure related.The patient was given vancomycin via peripherally inserted central catheter (picc).All components were explanted and the patient is currently doing well.The explanted devices were discarded.

Event Description

It was reported that the patient developed an infection at the ipg and lead incision sites.Symptoms of infection were wound drainage and the incision sites were hot to touch.The physician believed that the infection was device related and not procedure related.The patient was given vancomycin via peripherally inserted central catheter (picc).All components were explanted and the patient is currently doing well.The explanted devices were discarded.Additional information was received that symptoms of infection were redness and swelling.

• Brand Name: SPECTRA WAVEWRITER
• Type of Device: STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF
• Manufacturer (Section D): BOSTON SCIENTIFIC NEUROMODULATION; 25155 rye canyon loop; valencia CA 91355
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; cashel road; clonmel ; EI
• Manufacturer Contact: talar tahmasian ; 25155 rye canyon loop; valencia, CA 91355 ; 6619494863
• MDR Report Key: 10405076
• MDR Text Key: 202858039
• Report Number: 3006630150-2020-03421
• Device Sequence Number: 1
• Product Code: LGW
• UDI-Device Identifier: 08714729951254
• UDI-Public: 08714729951254
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P030017
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 02/09/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 03/20/2021
• Device Model Number: SC-1160
• Device Catalogue Number: SC-1160
• Device Lot Number: 352593
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/24/2020
• Initial Date FDA Received: 08/13/2020
• Supplement Dates Manufacturer Received: 01/25/2022
• Supplement Dates FDA Received: 02/09/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/26/2019
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 68 YR
• Patient Sex: Male